A Brief Analysis of Equivalence Demonstration Techniques for Clinical Evaluation of Medical Devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 328-331, 2023.
Article
in Chinese
| WPRIM
| ID: wpr-982239
ABSTRACT
This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2023
Type:
Article
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